Abdala (vaccine)

Abdala
Vaccine description
TargetSARS-CoV-2
Vaccine typeProtein subunit
Clinical data
Other namesABDALA
Routes of
administration
Intramuscular
Legal status
Legal status
  • Full and emergency authorizations
Full list of Abdala authorizations

Abdala, technical name CIGB-66, is a COVID-19 vaccine developed by the Center for Genetic Engineering and Biotechnology in Cuba.[1] This candidate, named after a patriotic drama by Cuban independence hero José Martí, is a protein subunit vaccine containing COVID-derived proteins that trigger an immune response.[2] The full results of the clinical trial have not yet been published. This candidate followed a previous one called CIGB-669 (MAMBISA).[3]

The vaccine is one of two Cuba-developed COVID-19 vaccines which has passed Phase III trials,[4][5][6] and has received emergency authorisation.

Medical uses

The vaccine was administered in 3 doses spaced 2 weeks apart.[7]

Efficacy

On 22 June 2021, The official Cuban government sources reported that the results of an initial study by the Cuban Center for Genetic Engineering and Biotechnology involving 48,290 participants found a 92.28% efficacy rate[8][9][10][11] at preventing symptomatic COVID-19.[12][13] The report included a confidence interval of 85.74%–95.817% without a specified confidence level; analysis was based on 153 cases of symptomatic COVID, 142 of which were in the placebo group and 11 of which were in the approximately equal vaccinated group.[13]

The measure of efficacy includes the initial strain of SARS-COV-2 as well as variants that were present in Cuba during the study,[14] including Alpha, Beta, and Gamma strains.[12] The Beta variant entered Cuba in January 2021 and became the predominant strain in Cuba,[15][16][17] fuelling a rise in COVID cases.[18]

As of 28 June 2021, Cuba has not yet released detailed information about the vaccine to the WHO[11] or to the general public via a pre-print or a scientific article.[19] It is planned to do so after the Cuba Health Agency (CECMED) authorises the vaccine for emergency use.[13][20]

Vaccine design

The vaccine was designed by researchers from the Center for Genetic Engineering and Biotechnology and has been described in a pre-print submission.[21] The Abdala vaccine reportedly consists of a monomeric receptor binding domain subunit, residues 331-530 of the Spike protein of SARS-CoV-2 strain 156 Wuhan-Hu-1, expressed in the yeast Pichia pastoris at 30–40 mg/L fermentation yield.[22] The vaccine antigen is polyhistidine-tagged to aid purification and is reportedly purified via immobilised metal affinity chromatography and subsequent hydrophobic interaction chromatography to >98% purity.[23] For animal studies 50 µg of vaccine antigen per dose was adjuvanted with 0.3 mg aluminum hydroxide gel (Alhydrogel) and delivered in 500 µL phosphate buffer.[24]

Manufacturing

Venezuela has claimed that it will manufacture the vaccine[25] but, as of 2 May 2021, this claim had not yet materialised.[26] State-owned EspromedBIO will manufacture the vaccine but some "arrangements" are needed to start production.[27] In April, Nicolás Maduro said that a capacity of 2 million doses per month is hoped to be reached by August or September 2021.[28] In June 2021, Vietnam's Ministry of Health announced that negotiations were ongoing between Cuba and Vietnam for Abdala vaccine production. The Institute of Vaccines and Medical Biologicals (IVAC) was named as the focal point for receiving technology transfer.[29]

History

Clinical trials

In July 2020, Abdala commenced phase I/II clinical trials.[30]

The Phase III trial compares 3 doses of the vaccine administered at 0, 14 and 28 days against a placebo, with the primary outcome measuring the proportion of cases reported for each group 14 days after the third dose. The trial was registered on 18 March 2021. The first dose was administered on 22 March and by April 4, the 48,000 participants had received their first dose,[31][32] and second doses started being administered from April 5.[33][34] Third doses have started being administered on 19 April[35][36][37] and on May 1, adherence to the three-dose protocol was over 97%.[38]

In July 2021, Abdala started clinical trial phase I/II for children and adolescents aged 3-18.[39]

Intervention study

124,000 people aged 19 to 80 received 3 doses of the vaccine as part of an intervention study, with the primary outcome measuring the proportion of cases and deaths for the vaccinated compared to the unvaccinated population.[40]

A wider intervention study with the 1.7 million inhabitants of Havana is expected to start in May with the Abdala and Soberana 2 vaccine.[41]

Authorizations

  Full authorization
  Emergency authorization
  Allowed for travel

On 9 July 2021, Abdala approved for an emergency use authorization in Cuba.[42][43]

On 18 September 2021, Abdala was approved for an emergency use authorization in Vietnam.[44]

On 16 December 2021, the Ministry of Health of Saint Vincent and the Grenadines announced that the Abdala vaccine was available at vaccination sites across the island.[45] This announcement follows a donation of vaccines made by the Cuban government on 13 December 2021.[46]

On 29 December 2021, Abdala was approved for an emergency use authorization in Mexico.[47]

Economics

On 24 June 2021, Vice President of Venezuela Delcy Rodríguez announced that Venezuela had signed a contract for 12 million doses of the vaccine, and that these doses are to arrive in "the coming months".[48] The first shipment of Abdala arrived in Venezuela the day following this announcement.[49]

On 20 September, 2021, The Vietnamese Government has issued a resolution on purchase of 10 million doses of Abdala COVID-19 vaccine.[50]

References

  1. ^ "ABDALA Clinical Study". rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 22 March 2021.{{cite web}}: CS1 maint: url-status (link)
  2. ^ Yaffe H (31 March 2021). "Cuba's five COVID-19 vaccines: the full story on Soberana 01/02/Plus, Abdala, and Mambisa". LSE Latin America and Caribbean blog. Retrieved 31 March 2021.
  3. ^ "MAMBISA Study". rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 22 March 2021.{{cite web}}: CS1 maint: url-status (link)
  4. ^ "Three-shot Cuban COVID-19 vaccine candidate moves forward in phase III". www.bioworld.com. Retrieved 10 April 2021.
  5. ^ "Cuba's Abdala COVID-19 vaccine enters phase 3 clinical trial - Xinhua | English.news.cn". www.xinhuanet.com. Retrieved 10 April 2021.
  6. ^ Zimmer C, Corum J, Wee SL. "Coronavirus Vaccine Tracker". The New York Times. ISSN 0362-4331. Retrieved 10 April 2021.
  7. ^ "ABDALA Clinical Study - Phase III". rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 22 March 2021.{{cite web}}: CS1 maint: url-status (link)
  8. ^ "Cuba says Abdala vaccine 92.28% effective against coronavirus". Reuters. 21 June 2021. Retrieved 25 June 2021.
  9. ^ Augustin, Ed (22 June 2021). "Cuba reports a high success rate for its homegrown Abdala vaccine". The New York Times. ISSN 0362-4331. Retrieved 25 June 2021.
  10. ^ "Cuba's COVID-19 vaccine Abdala shows 92 pct efficacy, makers say". Al Arabiya English. 22 June 2021. Retrieved 25 June 2021.
  11. ^ a b "Cuba says two of its vaccines are effective against COVID-19. But where is the data?". Miami Herald. 23 June 2021. Retrieved 25 June 2021.
  12. ^ a b "Abdala, con tres dosis, tiene una eficacia de 92,28 % (+Video)". Granma.cu (in Spanish). Retrieved 22 June 2021.
  13. ^ a b c "How was the efficacy of the Cuban COVID-19 vaccine candidates calculated?". OnCubaNews English. 27 June 2021. Retrieved 28 June 2021.
  14. ^ "Efficacy, resistance to variants, approval … 3 things to know about the Cuban vaccine Abdala". News in 24 english. 22 June 2021. Retrieved 28 June 2021.
  15. ^ Ministerio de Salud Pública en Cuba (22 January 2021). "Cuba reporta la presencia de una nueva variante genética de SARS-CoV-2". Sitio oficial de gobierno del Ministerio de Salud Pública en Cuba (in European Spanish). Retrieved 25 June 2021.{{cite web}}: CS1 maint: url-status (link)
  16. ^ "Cuba reports new coronavirus variant amid peak of cases". The Brazilian Report. 22 January 2021. Retrieved 25 June 2021.
  17. ^ "Cuba detects South African COVID-19 variant amid virus uptick". Miami Herald. Retrieved 25 June 2021.
  18. ^ Acosta, Nelson (22 April 2021). "South African virus variant fuels record Cuban COVID-19 cases". Reuters. Retrieved 25 June 2021.
  19. ^ Dourado, Eli (2020). "Accelerating Availability of Vaccine Candidates for COVID-19". SSRN Electronic Journal. doi:10.2139/ssrn.3564664. ISSN 1556-5068. S2CID 219394200.
  20. ^ Welle (www.dw.com), Deutsche. "COVID-19: las vacunas cubanas son una "esperanza" para América Latina | DW | 23.06.2021". DW.COM (in European Spanish). Retrieved 28 June 2021.
  21. ^ Limonta-Fernández, Miladys. "The SARS-CoV-2 receptor-binding domain expressed in Pichia pastoris as a candidate vaccine antigen July 3, 2021". medrxiv.org. Retrieved 23 November 2021.
  22. ^ Limonta-Fernández, Miladys. "The SARS-CoV-2 receptor-binding domain expressed in Pichia pastoris as a candidate vaccine antigen July 3, 2021". medrxiv.org. Retrieved 23 November 2021.
  23. ^ Limonta-Fernández, Miladys. "The SARS-CoV-2 receptor-binding domain expressed in Pichia pastoris as a candidate vaccine antigen July 3, 2021". medrxiv.org. Retrieved 23 November 2021.
  24. ^ Limonta-Fernández, Miladys. "The SARS-CoV-2 receptor-binding domain expressed in Pichia pastoris as a candidate vaccine antigen July 3, 2021". medrxiv.org. Retrieved 23 November 2021.
  25. ^ "Cuba says it's 'betting it safe' with its own Covid vaccine". NBC News. Retrieved 10 April 2021.
  26. ^ "Maduro struggles to make his grand vaccine promise". Eminetra.co.uk. 2 May 2021. Retrieved 3 May 2021.{{cite web}}: CS1 maint: url-status (link)
  27. ^ "Venezuela producirá la vacuna cubana anticovid Abdala". www.efe.com (in Spanish). Retrieved 3 May 2021.
  28. ^ "Venezuela to produce Cuban COVID vaccine: Maduro". Aljazeera.com. Al Jazeera and news agencies. 12 April 2021. Retrieved 23 June 2021. We've signed an agreement to produce in our laboratories… two million vaccines a month of the Abdala vaccine… for August, September, approximately,
  29. ^ Ministry of Health Vietnam (16 June 2021). "Bộ trưởng Bộ Y tế đàm phán với Cuba về hợp tác sản xuất vaccine". giadinh.net.vn (in Vietnamese). Retrieved 17 June 2021.{{cite web}}: CS1 maint: url-status (link)
  30. ^ "ABDALA Clinical Study". rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 21 March 2021.{{cite web}}: CS1 maint: url-status (link)
  31. ^ BioCubaFarma (4 April 2021). "[Translated] "The application of the 1st dose of #Abdala, in volunteer 48 thousand, of the Phase III Clinical Trial. Next Monday, April 5, the application of the 2nd dose of this vaccine candidate begins. #VcaunasCubanasCovid19 ."". Twitter. Retrieved 10 April 2021.{{cite web}}: CS1 maint: url-status (link)
  32. ^ "Covid Check-in: Cuba's Homegrown Vaccines". AS/COA. Retrieved 10 April 2021.
  33. ^ BioCubaFarma (5 April 2021). "[Translated] "The application of the 2nd dose of the vaccine candidates begins today #Abdala and #Soberana02 , as part of the 3rd phase of the clinical trial. Workers of @Emcomed1 in Havana and eastern provinces, from very early hours they carry out their distribution until the vaccination centers"". Twitter (in Spanish). Retrieved 10 April 2021.{{cite web}}: CS1 maint: url-status (link)
  34. ^ "Two Cuban Vaccines Start Second Dose Phase III Trials". Kawsachun News. 5 April 2021. Retrieved 10 April 2021.
  35. ^ "Abdala: Comienza tercera dosis en el Oriente cubano". www.cuba.cu (in Spanish). Retrieved 21 April 2021.
  36. ^ BioCubaFarma. "[Translated] "Application of the 3rd dose of the vaccine candidate begins #Abdala in the provinces of Granma, Santiago de Cuba and Guantánamo. The application of the 2nd dose of #Soberana02 within the framework of the EC Phase III.#VacunasCubanasCovid19". Twitter. Retrieved 21 April 2021.{{cite web}}: CS1 maint: url-status (link)
  37. ^ Noticias, Agencia Cubana de. "Convergen múltiples voluntades para éxito de estudio Abdala en Bayamo". ACN (in European Spanish). Retrieved 21 April 2021.
  38. ^ Rodriguez, Maby; Sánchez, Liz (4 May 2021). "With Abdala, Cuba takes another step toward broad scale vaccination". Granma. Retrieved 2 July 2021.
  39. ^ "Evaluation of the safety and immunogenicity of the vaccine candidate "ABDALA" in children and adolescents". rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 7 July 2021.{{cite web}}: CS1 maint: url-status (link)
  40. ^ "ABDALA-Intervention | Registro Público Cubano de Ensayos Clínicos". rpcec.sld.cu. Retrieved 10 April 2021.
  41. ^ Ministerio de Salud Pública en Cuba. "Sitio oficial de gobierno del Ministerio de Salud Pública en Cuba". Sitio oficial de gobierno del Ministerio de Salud Pública en Cuba (in European Spanish). Retrieved 23 April 2021.{{cite web}}: CS1 maint: url-status (link)
  42. ^ "COVID: Cuba approves emergency use of own Abdala vaccine". Deutsche Welle. 9 July 2021. Retrieved 9 July 2021.
  43. ^ "Aprueba el CECMED el Autorizo de Uso de Emergencia del candidato vacunal cubano ABDALA | CECMED". www.cecmed.cu (in Spanish). Retrieved 9 July 2021.
  44. ^ Nga, Le (18 September 2021). "Vietnam approves emergency use of Cuba's Covid vaccine". VnExpress. Retrieved 18 September 2021.
  45. ^ "Vincentians have access to Cuban Abdala vaccine | Loop Caribbean News". Loop News. Retrieved 28 December 2021.
  46. ^ "SVG receives 300 Abdala vaccines from Cuba". SVG-TV. 21 December 2021. Retrieved 28 December 2021.
  47. ^ Garrison, Cassandra (29 December 2021). "Mexico authorizes Cuban COVID-19 vaccine for emergency use". WTVB. Retrieved 29 December 2021.{{cite web}}: CS1 maint: url-status (link)
  48. ^ "Venezuela announces acquisition of 12 million Cuban vaccine doses". Macau Business. 25 June 2021. Retrieved 25 June 2021.
  49. ^ "Venezuela receives first shipment of Cuban coronavirus vaccine". Reuters. 24 June 2021. Retrieved 25 June 2021.
  50. ^ "Gov't to purchase 10 million doses of Cuba's COVID-19 vaccine". The Government of Vietnam. 20 September 2021. Retrieved 26 September 2021.

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